Niraparib Combined With Anlotinib in Homologous Recombination Repair (HRR) Gene-mutated Advanced Solid Tumors

Sponsor
Peking University Cancer Hospital & Institute
Study ID
NCT04764084
Phase
PHASE1
Status
Unknown

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 70 Years
Healthy Volunteers
Not accepted

Interventions

  • Niraparib — DRUG
    Niraparib 100mg or 200mg, PO, qd，d1-d21
  • Anlotinib — DRUG
    Anlotinib 12mg, PO, qd，d1-d14

Study Details

Homologous Recombination Repair (HRR) gene mutations can be detected in many solid tumors, patients with HRR gene mutations may benefit from PARP inhibitor. Antiangiogenic drugs can induce hypoxia and increase the sensitivity to PARP inhibitor. The combination of PARP inhibitor and antiangiogenic drug can play a synergistic anti-tumor role and achieve good efficacy in HRR gene-mutated tumors. The purpose of the study is to determine the dose limiting toxicity (DLT) and maximum tolerable dose (MTD) of Niraparib plus Anlotinib in HRR gene-mutated advanced solid tumors, and evaluate the safety and effectiveness of this combination therapy preliminarily.

Key Dates

Start date
Apr 1, 2021
Status verified
Feb 2021
Primary completion
Nov 1, 2021
Completion
Feb 28, 2023

Study Design

Enrollment
52 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Treatment group
    Niraparib-Anlotinib combination therapy

Primary Outcome Measure

Dose limiting toxicity (DLT) and maximum tolerated dose (MTD) [ Time Frame: 4 weeks ]

Central Contacts

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